Documents and Downloads

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Study Documentation (11 items)

Protocol (2 items)

Protocol - v 16 - last updated 17 October 2007

SPIRIT Protocol - v15 - last updated 14 June 2006

PIL/IC Form (3 items)

PIL/IC Form - v3 - last updated 17 October 2007

PIL/IC Form - v2 - last updated 08 January 2007

PIL/IC Form - v1 - last updated 20 July 2004

GP Letter (2 items)

GP Letter - v1 - last updated 26 March 2004

GP Letter - v2 - last updated 17 October 2007

SAE Form (1 items)

SAE Form - v3 - last updated 12 January 2009

Site Delegation Log (2 items)

Site Delegation Log - v1 - last updated 13 June 2005

Site Delegation Log - v2 - last updated 05 June 2006

Participant Log (1 items)

Participant Log - v1 - last updated 13 June 2005

Screening Log (1 items)

Screening Log - v1 - last updated 13 June 2005

Patient Booklet - How to take your study medication (2 items)

Patient Booklet - How to take your study medication - v1 - last updated 08 January 2007

Patient Booklet - How to take your study medication - v2 - last updated 24 October 2007

Document Version Control List - last updated 13 January 2011

This document lists the version control history of documents in use on the SPIRIT 1 Trial.

Site Laboratory Normals Form - v1 - last updated 13 June 2005

eCRF completion guidelines - last updated 28 March 2008

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Pharmacy (7 items)

IB (PEG Interferon alpha-2a) ( Private category, login required. )

Pharmacy manual - v7.0 - last updated 10 June 2009

Prescription - Arm A - 400mg Imatinib - v2 - last updated 19 January 2006

Prescription - Arm B - 800mg Imatinib - v2 - last updated 19 January 2006

Prescription - Arm C - 400mg Imatinib + Pegasys - v3 - last updated 08 January 2007

Dispensing and Returns Log - v2 - last updated 30 May 2006

Drug receipt log - v2 - last updated 30 May 2006

MHRA (12 items)

Imatinib DDX - last updated 16 March 2004

Peginterferon alpha-2a DDX - last updated 02 January 2004

MHRA confirmation of DDX rollover to CTA - last updated 21 April 2004

Conversion of DDX exemptions to Clinical Trial Authorisation

Amendment 1 - Substantial Amendment Notification - signed - last updated 14 July 2006

Amendment 1 - MHRA Approval - last updated 14 September 2006

Also includes MREC approval dated 01 Sept 06

Amendment 2 - Cover letter to MHRA - last updated 20 November 2007

Amendment 2 - Substantial Amendment Notification - unsigned - last updated 17 October 2007

Amendment 2 - MHRA Approval - last updated 09 January 2008

Amendment Planned Cessation of Recruitment Dec08 - Cover letter to MHRA - last updated 19 December 2008

Amendment Planned Cessation of Recruitment Dec08 - Substantial amendment notification - last updated 19 December 2008

Amendment Planned Cessation of Recruitment Dec08 - MHRA Approval - last updated 07 January 2009

Response to comment in MHRA Notification Amendment 2 - last updated

 

Ethics (10 items)

MREC application form - unsigned - last updated 26 March 2004

MREC application form - signature page - last updated 26 March 2004

MREC approval - last updated 20 August 2004

Amendment 1 - substantial amendment notification - last updated 08 January 2007

Amendment 1 - MREC approval - last updated 15 January 2007

Amendment 2 - substantial amendment notification - last updated

Amendment 2 - MREC approval - last updated 12 November 2007

Amendment Planned Cessation of Recruitment Dec08 - main REC cover letter - last updated 19 December 2008

Amendment Planned Cessation of Recruitment Dec08 - Substantial amendment notification - last updated 19 December 2008

Amendment Planned Cessation of Recruitment Dec08 - main REC response - last updated 06 January 2009

Sponsor (2 items)

Letter of Sponsorship - last updated 18 February 2004

Sponsor Indemnity - last updated 09 March 2004

Presentations (4 items)

NCRI CML WG presentation May 2008 - last updated

NCRI CML Working Group presentation given at Annual Review of Leukaemia meeting in May 2008. Includes preliminary high-level results from SPIRIT 1 study and an overview of the SPIRIT 2 Study.

Site Initiation Presentation - last updated 12 November 2008

SPIRIT Presentation from CML Conference 17 Nov 2008 - last updated

 

SPIRIT Presentation CML Conference Cambridge - last updated

 

Patients (0 items)

Safety Reports (2 items)

SUSARs (PEG Interferon alpha-2a) ( Private category, login required. )

SPIRIT Annual Safety Report 2009-10 - last updated 04 February 2010

Contact Information

Wendy Banks

Trial Secretary

Landline: 0191 282 0904

Mobile:

Fax: 0191 376 0748

Email: wendy.banks@ncl.ac.uk

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